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Results For "phase-3"

732 News Found

Merck to acquire Acceleron for US $ 11.5 billion
News | October 01, 2021

Merck to acquire Acceleron for US $ 11.5 billion

The acquisition complements and strengthens Merck’s cardiovascular pipeline


Aurobindo subsidiary submits MAA for oncology biosimilar
Biotech | September 23, 2021

Aurobindo subsidiary submits MAA for oncology biosimilar

CuraTeQ Biologics is on track for filing a second oncology biosimilar


Pfizer and BioNTech’s Covid-19 vaccine safe for children aged 5 to 11: study
Biotech | September 21, 2021

Pfizer and BioNTech’s Covid-19 vaccine safe for children aged 5 to 11: study

In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralising antibody responses. Results in children under 5 years of age are expected as soon as later this year


BMS receives positive CHMP opinion for Opdivo
Drug Approval | September 18, 2021

BMS receives positive CHMP opinion for Opdivo

The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy


Canada approves Moderna’s Covid-19 vaccine
Drug Approval | September 17, 2021

Canada approves Moderna’s Covid-19 vaccine

In the final analysis of Phase 3 COVE study data, SPIKEVAX showed 93% efficacy, with the efficacy remaining durable through six months after the administration of the second dose


Lancet study confirms Johnson & Johnson Ebola vaccine safe
Drug Approval | September 16, 2021

Lancet study confirms Johnson & Johnson Ebola vaccine safe

Data show the vaccine regimen induced neutralising antibody responses in nearly all participating adults and children 21 days after the second dose. Adults receiving booster shots two years after the initial vaccination regimen showed strong immune responses


US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma
Drug Approval | September 12, 2021

US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma

Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma


Novavax initiates Phase 1/2 trials combining vaccine for Covid-19 and seasonal influenza
Biotech | September 09, 2021

Novavax initiates Phase 1/2 trials combining vaccine for Covid-19 and seasonal influenza

First participants enrolled in Phase 1 clinical trial of combination NanoFlu/NVX-CoV2373 vaccine with Matrix-M adjuvant. The Phase 1/2 study will also evaluate immunogenicity and safety


Merck’s KEYTRUDA receives China approval for Esophageal cancer
Drug Approval | September 09, 2021

Merck’s KEYTRUDA receives China approval for Esophageal cancer

The medicine is now approved for eight indications across five different types of cancer in China.


RenovoRx receives New 510(k) clearance from US FDA
News | September 08, 2021

RenovoRx receives New 510(k) clearance from US FDA

The company’s RenovoCath Delivery System designed for targeted treatment of solid tumours